Method Development, Transfer and Validation

Whether you need expert testing consultation, method development or validation protocol design, Eurofins Sinensis offers you the widest range of laboratory techniques in the industry. We support customers at various stages of the development / validation process and have a proven track record of success on full development and validation studies, optimization of existing research methods and transfer of previously validated methods.


Method Development and Validation Services for:
 

Chemistry/Biochemistry

  • Assay/Potency, Purity/Impurity, Dissolution
  • Cleaning Validation Analysis (Specific and Nonspecific analyses)
  • Assay, Impurity and Dissolution methods for Comparator products
  • Residual/Impurities Testing
  • Stress Testing
  • Complaint vials
  • Excipients
     

Microbiology

  • Bacteriostatis/Fungistatis for Sterility
  • Inhibition/Enhancement Screening for Endotoxin
  • AET and Microbial Limit
     

Molecular and Cell Biology

  • Cell-based Assays
  • ELISA
  • qPCR
     


Why Choose Eurofins Sinensis?

  • Dedicated project leaders collaborate closely with our customers to generate compliant protocols in accordance with ICH guidelines.
  • Quick turnaround time on feasibility assessment of the methods, execution of the protocol and generation of the final report.
  • A flexible process that allows on-site training at our laboratory or travel to the client site for more complex and/or technique-based methods.

Questions? Call us now

+31 (0)71 524 4080